Hand holding Finacea® Foam
Not actual size.

Proven efficacy in a foam vehicle.1
That’s Finacea® Foam.

Reduction in inflammatory lesion count

PRIMARY ENDPOINT: Mean nominal changes in inflammatory lesion count from baseline to end of 12-week treatment period1-3

Trial 1 Inflammatory Lesion Count reduction - Finacea® Foam vs foam vehicle
Trial 2 Inflammatory Lesion Count reduction - Finacea® Foam vs foam vehicle

Significant reduction in the mean number of inflammatory lesions with Finacea® Foam vs foam vehicle* at 12 weeks.4

*Foam vehicle contained the same exact hydrophilic foam minus azelaic acid.1
†End of trial.
‡P-value is calculated from 2-sided t test.

IGA* success rates

PRIMARY ENDPOINT: IGA success rate from baseline to end of 12-week treatment period1-3

Trial 1 IGA success rate - Finacea® Foam vs foam vehicle
Trial 2 IGA success rate - Finacea® Foam vs foam vehicle

Clinical results: Superior success rates with Finacea® Foam vs foam vehicle¶1

*Investigator's Global Assessment.
†P-value is calculated from the Pearson χ2 test.
‡End of trial.
¶Foam vehicle contained the same exact hydrophilic foam minus azelaic acid.1

STUDY DESIGN1

  • Two pivotal, multicenter, randomized, double-blind, vehicle-controlled, 12-week clinical trials involving a total of 1,362 patients (active N=681; vehicle N=681)
  • Finacea® Foam was compared to its foam vehicle* without azelaic acid
  • Subjects' ages ranged from 19 to 92 years (mean age 50.6 years). 95.7% of subjects participating in the trials were Caucasian and 73.4% were female
  • Enrolled patients had papulopustular rosacea with a mean lesion count of 21.3 (range 12 to 50) inflammatory papules and pustules
  • Exclusion criteria:
    • Those with ocular rosacea, phymatous rosacea, or plaque-type rosacea lesions
    • Those with rosacea that requires systemic treatment
    • Those who are known nonresponders to azelaic acid
    • Those with a known hypersensitivity to any ingredients of the study drug
  • Finacea® Foam or the foam vehicle were to be applied twice daily for 12 weeks; no other topical or systemic medication affecting the course of rosacea and/or evaluability was to be used during the studies

The efficacy endpoints in the 2 clinical trials were:

Nominal change in inflammatory lesion count from baseline,
AND
success defined as a score of "Clear" or "Minimal" with at least a 2-step reduction from baseline on a 5-point IGA.

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IGA (criteria used to define success)1

Severe

Numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema

Moderate

Pronounced number of papules and or pustules, but less than numerous papules and or pustules; moderate erythema

Mild

Few papules and/or pustules; mild erythema

Minimal

Rare papules and/or pustules; faint, up to but not including mild erythema

Clear

No papules and/or pustules; no erythema

Graphic representation is for illustrative purposes only.

Success is defined as at least a 2-step reduction

Success is defined as a score of "Clear" or "Minimal" with at least a 2-step reduction, "Moderate" to "Minimal" from baseline, or "Mild" to "Clear" from baseline on a 5-point IGA.1

Adverse reactions with Finacea® Foam versus foam vehicle

Adverse reactions occurring in ≥0.5% of subjects in both

*Foam vehicle contained the same exact hydrophilic foam minus azelaic acid.
†Application site pain is a term used to describe disagreeable skin sensations, including burning, stinging, paraesthesia, and tenderness.

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References:

  1. Finacea® Foam [prescribing information]. LEO Pharma Inc.
  2. Draelos ZD, Elewski BE, Harper JC, et al. A randomized, phase 3, double-blind, vehicle-controlled clinical trial to evaluate the safety and efficacy of 12 weeks of twice-daily azelaic acid foam, 15% in papulopustular rosacea. Poster presented at: 35th Anniversary Fall Clinical Dermatology Conference; Las Vegas, Nevada; October 20-23, 2016.
  3. Draelos ZD, Elewski B, Staedler G, et al. Azelaic acid foam 15% in the treatment of papulopustular rosacea. A randomized, double-blind, vehicle controlled study. Cutis. 2013;92(1):306-317.
  4. Data on file. LEO Pharma Inc.